U.S. Provisional Patent Filed  ·  Application No. 64/060,672  ·  May 8, 2026  ·  Patent Pending
Category · Dual-Arch Intraoral Capture

Full-arch intraoral capture, reimagined as one acquisition — not hundreds.

Odonteikon is building EIKONIS™: a dual-arch intraoral scanner that captures the maxilla and mandible simultaneously inside a calibrated, bite-stabilized geometry. One seat. One acquisition. A full-arch dataset ready for restorative, orthodontic, and implant planning.

U.S. Patent Pending · App. No. 64/060,672 Dual-Arch Sensor System Embedded Compute Wireless Roadmap 510(k) Pathway
EIKONIS intraoral capture device — translucent mouthpiece with three optical cameras and tethered control unit
EIKONIS™ · ACTUAL DEVICE
Stage Engineering validation · U.S. Provisional Filed May 8, 2026
Regulatory Pathway FDA 510(k) · CE MDR
Inventor Jeffrey Retherford

U.S. Application No. 64/060,672 · Filed May 8, 2026

EIKONIS™ — Patent Drawings

Fifteen formal figures covering device geometry, sensor array layout, LED illumination pathways, occlusal registration, and charging system. U.S. Provisional Patent Pending.

EIKONIS patent drawings
EIKONIS™ · Dual-Arch Simultaneous Intraoral Capture System and Method U.S. App. No. 64/060,672 · Patent Pending
Fig. 02 · Device Overview

A wireless mouthpiece, not a wand.

EIKONIS™ · DEVICE SPECIFICATIONS TARGETED · ENGINEERING RELEASE
Form factor
Architecture Tethered intraoral mouthpiece + chairside control unit
Mouthpiece footprint ~70 × 52 × 22 mm
Mouthpiece weight < 35 g
Optical channels 3 — anterior labial, left buccal, right buccal
Illumination Internal LED arrays, both lateral walls
Reprocessing Autoclavable mouthpiece + single-use barrier sleeve
Capture & data
Acquisition time < 20 seconds, full arch
Capture mode Simultaneous maxilla + mandible
Bite registration Native — no separate registration step
Output formats STL · PLY · OBJ · DICOM
Trueness target ≤ 25 µm full-arch
Connectivity USB-C charge + sync · Wireless data path on roadmap
§ Illustrative architectural views Mechanical specifications finalized per engineering release
§ 01 · Thesis

Today’s scanners rely on an operator. Ours relies on geometry.

Current intraoral scanners — TRIOS, iTero, Primescan, Medit — are wand-based. An operator sweeps the device across each arch, and software stitches thousands of frames into a single mesh. The technique works, but it is slow, operator-dependent, and a well-known bottleneck on full-arch restorative and implant cases where retakes are most expensive.

EIKONIS™ replaces the motion model with a fixed, calibrated dual-channel architecture. The patient bites into the device. Both arches are captured in parallel through structured optical channels with known geometry. The result is a dataset that is, by design, more repeatable across operators and dramatically faster on full-arch acquisitions.

§ 02 · Architecture

What makes EIKONIS™ structurally different.

01 / 05

Dual-arch simultaneous capture

Both arches imaged in a single acquisition inside a bite-stabilized housing. Target full-arch scan time measured in seconds, not minutes.

02 / 05

Calibrated in-mouth geometry

Sensor positions, viewing angles, and illumination pathways are fixed and factory-calibrated. Removes a major source of inter-operator variability.

03 / 05

Embedded compute

On-device preprocessing and compression reduce tethered bandwidth requirements and create headroom for AI-assisted capture validation in future releases.

04 / 05

Wireless-ready roadmap

Designed for a three-stage deployment path: tethered launch, dock-charged mobile, fully wireless — all sharing the same core architecture.

05 / 05

Thermal engineering

Distributed substrate design keeps intraoral surface temperature within target range across sustained duty cycles, without active cooling.

IP / 05

Patent foundation

Applications filed covering the dual-arch geometry, bite-stabilization mechanics, thermal substrate, and workflow integration layer.

§ 03 · Where we are

A serious company, honestly staged.

Odonteikon is a pre-commercial medical-device company. The platform is currently in engineering validation with active patent prosecution and predicate-device analysis for 510(k) submission. We do not market capabilities we have not built. A full diligence package is available under NDA to qualified parties.

Patents 05filings
Regulatory 510(k)planned
Target scan time < 20sec
Full-arch trueness ≤ 25μm
§ 04 · Foundation

Four pillars of institutional credibility.

01
Intellectual Property
Patent family covering geometry, sensing, thermal, and workflow layers. Filing jurisdictions: US, PCT.
02
Engineering Discipline
Product designed around mechanical and optical constraints first. Claims reflect filed IP and measured targets.
03
Regulatory Readiness
Predicate device strategy, QMS preparation, and 510(k) pathway documented in the diligence package.
04
Clinical Alignment
KOL program active for design input on full-arch restorative, implant, and orthodontic workflows.
§ 05 · Market

A category primed for architectural disruption.

Intraoral scanning is one of the fastest-growing segments in dental technology, and the curve is accelerating. Digital dentistry is no longer an early-adopter stance — it is becoming the clinical baseline across restorative, orthodontic, and implant workflows. Yet every major scanner on the market shares the same sequential wand motion model that has defined the category for more than a decade.

The underlying demand drivers are durable: an aging patient population, the rise of full-arch implant-supported restoration, DSO consolidation demanding standardized workflows, and clear aligner treatment scaling into general practice. Each of these pressures sharpens the penalty for slow, operator-dependent acquisition — and creates oxygen for an architecturally different approach.

Global IOS Market · 2024
~$1.2BN

Intraoral scanner hardware, software, and consumables across OEMs.

2030 Projection
~$3.4BN

Consensus range for global IOS market at current CAGR through 2030.

US Dental Practices
~200K

Addressable operatory footprint in the United States, including DSO and independent practices.

Full-Arch Cases · Growth
~15% CAGR

Global full-arch implant-supported restoration case volume growth rate.

Sources: Industry research · Grand View Research · Fortune Business Insights · ADA practice census
§ 06 · Compared

Where EIKONIS™ sits against a wand-based system.

The comparison is not feature-by-feature. It is architectural. Wand systems optimized a sequential scan motion that was invented before real-time 3D sensing was cheap. EIKONIS™ optimizes a different variable entirely: the in-mouth geometry itself.

Dimension
Incumbent class
Wand-based scanners
Odonteikon
EIKONIS™ dual-arch
Acquisition model
Sequential sweep across each arch, stitched frame-by-frame.
Simultaneous parallel capture — both arches in one acquisition.
Full-arch scan time
60 – 120 seconds per arch, operator-dependent.
Target < 20 seconds · both arches, fixed geometry.
Operator skill sensitivity
High. Hand motion, angle, and pacing affect mesh quality.
Low. Sensor geometry is fixed and factory-calibrated.
Inter-arch registration
Separate step. Error compounds across full-arch cases.
Eliminated. Both arches acquired in the same geometry.
Stitching artifacts
Persistent. Worst on full-arch and edentulous cases.
Absent. No frame-to-frame stitching across the arch.
Retake frequency
Common — especially in DSO, training, and high-volume practices.
Designed to minimize through geometric repeatability.
Form factor
Handheld wand. External to the bite geometry.
Wireless mouthpiece architecture. Patient bites onto the device.

The wand is the limit. Every downstream improvement — AI scrubbing, better stitching, faster GPUs — works around a bottleneck that is upstream of software.

§ Architecture thesis
§ 07 · Connect

Serious conversations, serious partners.

Odonteikon engages through four dedicated channels. Each is monitored by the corresponding leadership lane.

Partnerships · OEM
Clinical · KOL Program
Platform · Technical Overview

The EIKONIS™ platform architecture.

A calibrated dual-arch intraoral imaging system designed for simultaneous full-arch capture, embedded preprocessing, and a wireless-capable hardware roadmap. Four integrated subsystems, one system thesis.

§ 01 · Subsystems

Four subsystems, integrated.

EIKONIS device showing translucent intraoral mouthpiece with three optical cameras and warm-white LED illumination, tethered to white square control unit with EIKONIS branding, status LED, and USB-C port
01

Dual-channel optical head

Two optical pathways — one maxillary, one mandibular — housed in a bite-stabilized geometry. Each channel uses structured-light acquisition, factory-calibrated against a known reference geometry. The fixed relationship between channels eliminates the maxilla-to-mandible registration step that wand systems require in post-processing.

02

Embedded compute spine

On-device SoC handling frame acquisition, preprocessing, compression, and telemetry. Designed to offload up to 60% of preprocessing from the host workstation compared with current wand-based systems, and to host AI-assisted capture-validation layers in future releases.

03

Thermal management layer

Distributed substrate design keeps intraoral surface temperature within target range across sustained duty cycles. No active cooling, no fans. Thermal modeling documentation available under NDA as part of the technical diligence package.

04

Communications & power

Tethered USB-C at launch. Dock-charged mobile in the second-generation housing. Fully wireless capture in the third. All three stages share the core optical and compute architecture — the platform roadmap does not require re-engineering the imaging thesis.

§ 02 · Engineering Depth

The system, in technical detail.

EIKONIS™ is a structured-light dual-arch capture system. Below is a more detailed view of how the optical, calibration, signal-processing, and thermal subsystems work together to produce a calibrated full-arch dataset in a single bite-down acquisition.

Three calibrated channels, one fixed geometry.

The mouthpiece carries three optical channels arranged for full-arch coverage: an anterior labial channel for incisor and canine geometry, and two buccal channels positioned at the posterior of each lateral wall for premolar and molar coverage. Each channel is a structured-light pair — an emitter projecting a calibrated pattern paired with a high-frame-rate imaging sensor.

Channels operate in time-multiplexed sequence within an acquisition window. Pattern projection, sensor exposure, and frame readout are coordinated by the onboard SoC so that maxillary and mandibular coverage of each region is captured under known geometric constraints. Because the optical heads are bonded into a single rigid mouthpiece chassis, the relative pose of every channel is established once at factory calibration and held by mechanical design rather than re-derived from features in each scan.

Trueness is held by the device, not the scan.

Trueness in intraoral scanning is a function of two things: the inherent accuracy of each capture frame, and the cumulative error introduced by stitching frames into a continuous mesh. EIKONIS™ eliminates the second source by design — the dual-arch geometry is captured in a single coordinated acquisition with no operator-driven motion path.

Each device is factory-calibrated against a traceable reference geometry. Calibration data is stored in the mouthpiece itself and applied at the point of capture. A periodic in-clinic verification routine, run against a small calibration block, is used to detect drift across the device’s service interval. The metrology target for full-arch trueness is ≤ 25 µm, and the validation strategy follows the methodology described in ISO 12836 for intraoral scanner accuracy assessment.

From photons to mesh, mostly in-device.

Raw frame data from each imaging sensor is processed by the onboard SoC located in the chairside control unit. The pipeline runs frame validation, structured-light decoding, point-cloud generation, and lossless compression before transmitting to the host. Designed to offload the majority of the preprocessing burden from the workstation — a meaningful difference from wand-based scanners that rely on host-side stitching for every acquisition.

The output dataset is a calibrated mesh of both arches plus their bite relationship, exported in STL, PLY, OBJ, or DICOM. Open formats are a deliberate architectural choice: the platform thesis is that a cleaner upstream dataset should make every downstream tool work better, not require replacing them.

Patient-contact, autoclavable, thermally bounded.

The mouthpiece shell is a medical-grade biocompatible polymer (polycarbonate or polyetherimide class), translucent for visual seating confirmation and rigid enough to hold the factory-calibrated optical-channel pose under bite load. The polymer is selected to withstand repeat steam autoclave cycles at ≥ 134 °C across the device’s service life. Patient-contact surfaces are designed for use with a single-use disposable barrier sleeve covering the underlying mouthpiece during use — the same reprocessing pattern clinicians already apply to existing intraoral scanners. Optical windows are coated for visible-spectrum throughput and resistance to standard dental-operatory disinfectants.

Active electronics — the imaging sensors, structured-light emitters, and illumination LEDs — produce heat at the patient-contact interface. The PCB substrate is selected for thermal conductivity and is mechanically coupled to a heat-spreading layer that moves heat away from the patient-facing surfaces toward the posterior of the device. An independent hardware supervisory circuit, separate from the main compute path, monitors contact-surface temperatures at multiple points and latches capture off if any approaches the regulatory thermal limit defined in IEC 60601-1 clause 11. This is a hardware safety boundary, not a software check — required to satisfy single-fault analysis under IEC 60601-1 clause 4.7.

Photobiological safety of the structured-light emitters and illumination LEDs is evaluated under IEC 62471 (photobiological safety of lamps and lamp systems), with particular attention to the visible-spectrum emission profile and the working distance to the dental and mucosal surfaces.

§ 03 · Performance

Target performance.

— Design targets, not shipping specifications. Current measured values in the technical packet.

Full-arch acquisition time < 20 seconds · both arches Target
Full-arch trueness ≤ 25 μm Target
Inter-operator variability < 10 μm σ across operators Target
Host workstation requirement Windows 11 · Intel i7 / Ryzen 7 · 32 GB RAM · NVIDIA RTX 3060 or equivalent
Sterilization pathway Autoclavable optical tip · single-use barrier sleeve
Output format STL, PLY, OBJ, DICOM mesh
§ 04 · Intellectual Property

A patent family around the whole architecture.

  • IP · 01 The dual-arch simultaneous acquisition geometry — parallel optical channels with fixed relative positioning.
  • IP · 02 Bite-stabilization and occlusal-reference mechanics that establish the calibrated in-mouth environment.
  • IP · 03 Thermal substrate and power distribution for sustained intraoral operation without active cooling.
  • IP · 04 The workflow-integration layer between device output and third-party planning, CAD/CAM, and treatment-planning software.

Filing jurisdictions: US, PCT. A patent family summary is available under NDA.

§ 05 · Regulatory

Pathway clarity from day one.

EIKONIS™ is intended to pursue FDA 510(k) clearance in the United States and CE marking under MDR in the European Union. Predicate-device analysis is complete; the submission strategy and Quality Management System status are documented in the diligence package.

The regulatory roadmap is deliberately conservative. Each generation of the platform — tethered, dock-charged, wireless — is sequenced to minimize submission risk while preserving architectural continuity for investors and strategic partners.

§ 06 · Quality & Compliance

Built to the standards we’ll be cleared against.

EIKONIS™ is being engineered from day one against the standards relevant to a Class II intraoral scanner pursuing FDA 510(k) clearance and CE marking under MDR. What follows is the design-controls, risk, and standards posture targeted for engineering release. None of it is a clearance claim — it is the framework the device is being built within.

6.1 · Design controls

21 CFR 820.30 from the start.

The development process is structured around FDA design-control requirements: documented design inputs traceable to user needs, design outputs that meet those inputs, design verification at the subsystem level, and design validation against intended use. The Design History File is maintained as a living artifact throughout development — not assembled retrospectively before submission.

6.2 · Risk management

ISO 14971 across the full lifecycle.

Risk analysis follows ISO 14971:2019, with hazard identification covering optical safety, electrical safety, thermal exposure at patient contact, mechanical hazards including bite-loading, biocompatibility, software malfunction modes, and reprocessing failure modes. Risk-control measures are traceable to design outputs; residual risk is evaluated against benefit per the standard’s revised framework.

6.3 · Software lifecycle

IEC 62304, segregated by safety class.

Device software is developed under IEC 62304:2006/A1:2015. The capture-pipeline firmware running on the mouthpiece SoC and the host-side data-handling layer are segregated by safety class so that safety-relevant components are isolated and verified against the higher rigor required for their classification. Cybersecurity considerations follow FDA guidance on premarket submissions for medical-device software, including SBOM generation and threat modeling.

6.4 · Biocompatibility

ISO 10993 plus ISO 7405 for dental contact.

Patient-contact materials are evaluated under ISO 10993-1:2018, scoped per the device’s categorization as a surface-contacting device with prolonged mucosal exposure (24 hours to 30 days cumulative). Cytotoxicity (ISO 10993-5), sensitization (ISO 10993-10), and irritation (ISO 10993-23) testing are planned for the production-equivalent mouthpiece configuration. Chemical characterization (ISO 10993-18) and toxicological risk assessment (ISO 10993-17) support material grade selection where extractable or leachable concerns are identified. The dental-specific biocompatibility framework under ISO 7405:2018 is applied where indicated. The autoclave-and-barrier-sleeve reprocessing model is validated end-to-end rather than per-component.

6.5 · Electrical safety & EMC

IEC 60601-1 and -1-2 as the floor.

The chairside control unit and tethered mouthpiece are engineered to IEC 60601-1 (general requirements for basic safety and essential performance) and IEC 60601-1-2 (electromagnetic compatibility). Particular attention is paid to clause 11 thermal limits at the patient-contact interface and to the supervisory circuit that enforces those limits in hardware.

6.6 · QMS framework

ISO 13485 across both pathways.

The Quality Management System is being structured to meet ISO 13485:2016 to support both 510(k) submission and CE/MDR conformity assessment under a single QMS framework. Design controls under 21 CFR 820.30 sit inside the same QMS umbrella. Detailed scope, supplier qualification protocol, and process-validation strategy are documented in the diligence package available under NDA.

6.7 · Reprocessing & patient-contact

Validated barrier-sleeve plus autoclave model.

EIKONIS™ uses the same reprocessing pattern dental clinicians already apply to existing intraoral scanners: a single-use disposable polymer barrier sleeve isolates the underlying mouthpiece during patient use, and the underlying mouthpiece is steam-autoclaved between patients per validated instructions. The reprocessing chain is validated end-to-end against FDA Reusable Devices guidance and AAMI TIR12 / AAMI ST98 methodology. Cleaning-agent compatibility and cycle-life limits are documented in the reprocessing validation report.

6.8 · Manufacturing posture

Contract-manufactured to medical standards.

Initial manufacturing is contract-based with established medical-device CM partners carrying current ISO 13485 quality systems and recent FDA inspection history. CM-selection criteria require demonstrated capability for autoclave-rated polymer molding, electronic assembly to IPC-A-610 Class 3 (high-reliability), medical-device packaging compliant with ISO 11607, and the volume-scaling profile of a Class II device approaching commercial release. Geographic and trade-policy redundancy is structured into the CM portfolio.

§ 07 · Materials & Sourcing

Materials selected for the work they have to do.

The materials and components engineered into EIKONIS™ are selected against three constraints: patient safety in prolonged mucosal contact, mechanical and thermal stability across thousands of autoclave cycles, and supply-chain durability suitable for a medical device with a multi-year commercial lifecycle.

Patient-contact surfaces

Medical-grade biocompatible polymer for the mouthpiece shell, optical-grade glass or scratch-resistant polymer for the imaging windows, with a single-use disposable barrier sleeve as the primary patient-isolation layer. All materials are evaluated under ISO 10993 and ISO 7405 with the testing matrix scoped to the surface-contact, prolonged-exposure categorization.

Structural & thermal

Multi-layer high-temperature PCB substrate carrying calibrated imaging-sensor traces. Thermal-spreader layer mechanically bonded beneath, conducting heat from compute and imaging silicon away from the patient-contact surfaces. Internal mounting structure of glass-filled engineering thermoplastic to maintain optical-channel pose across thermal cycling.

Active components

Global-shutter CMOS imaging sensors per channel, paired structured-light pattern emitters, an embedded application-class system-on-chip with hardware structured-light decoding, sealed medical-grade lithium-ion cell pair, and a pre-certified Wi-Fi 6 / Bluetooth LE radio module to compress regulatory test scope at the finished-device level.

Sourcing posture

The bill of materials is structured to maximize commodity and dual-sourceable components, with targeted supplier-qualification on specialty parts (imaging sensors, biocompatible polymer grade, lithium-ion cells). Sole-source parts — SoC, structured-light projection module, optical-window coating — carry documented long-term-availability commitments and architectural flexibility for second-source qualification.

§ 08 · Roadmap

Three generations, one architecture.

The EIKONIS™ platform is sequenced so each generation strengthens the same core thesis rather than re-engineering it. Tethered launch, dock-charged mobile, fully wireless — the optical head, compute spine, and imaging geometry carry forward.

2024 · 2025 Architecture & IP
  • — Core patent family filed
  • — Engineering validation
  • — Bench-level capture proof
  • — Bite-stabilization geometry locked
2026 Clinical prototype
  • — KOL program engagement
  • — Design input sessions
  • — Pre-submission FDA meeting
  • — QMS preparation
2027 510(k) & Gen 1
  • — 510(k) submission
  • — Tethered device launch
  • — Initial OEM / DSO pilots
  • — CE/MDR submission begins
2028 Gen 2 · Mobile
  • — Dock-charged mobile housing
  • — AI-assisted capture validation
  • — Expanded indication claims
  • — Commercial scale-up
2029+ Gen 3 · Wireless
  • — Fully wireless acquisition
  • — Platform software ecosystem
  • — Planning-software integrations
  • — International expansion
§ 09 · Architecture Pathways

Three architectures, one platform.

The same imaging core supports three productization pathways. Each pathway balances patient comfort against engineering complexity, and each one carries the optical head, compute spine, and bite-stabilization geometry forward unchanged. The launch generation is tethered; the platform extends from there.

Three wireless architecture concepts: Fully Wireless Mouthpiece with charging dock, Wireless Mouthpiece in Magnetic Dock case, and Semi-Wireless Hidden Cable control unit on belt
Fully Wireless Mouthpiece
FUTURE · GEN 3

Self-contained mouthpiece with embedded battery, onboard compute, and wireless data link to a charging dock.

Wireless + Magnetic Dock
INTERIM · GEN 2

Dock-charged workflow with a magnetic case for between-patient sterilization and storage.

Semi-Wireless · Hidden Cable
LAUNCH · GEN 1

Thin tether to a chairside control unit. Validated launch architecture with minimal patient-facing hardware.

Embedded Micro Battery
Sealed, surgically-rated cell architecture
Wireless Data Transmission
Low-latency mesh streamed to chairside or cloud
Edge Processing Onboard
Capture validation and compression in-device
Dock-Charged Workflow
Between-patient charging, no operator handling
Founder Recommendation EIKONIS™
Generation 1 Thin Tethered Smart Mouthpiece LAUNCH
Generation 2 Dock-Charged Wireless Mouthpiece FY28
Generation 3 Fully Wireless AI Imaging Architecture FY29+
MOUTHPIECE INTERNALS · COMPONENT STACK DESIGN INTENT · NOT FINAL BOM
Embedded Micro Battery

Sealed, surgically-rated cell pair sized for a full clinical session. Charged through the docked control unit; no operator handling between patients.

Wireless Antenna

Low-profile flex antenna integrated into the anterior module. Carries the live data path between the mouthpiece and chairside in Gen 2 and forward.

High-Speed Imaging Sensors

Three calibrated optical channels with factory-locked relative geometry. The fixed relationship is what eliminates the maxilla-to-mandible registration step.

Onboard Processing + Compression

SoC handles frame acquisition, preprocessing, and compression in-device. Designed to offload the majority of preprocessing from the host workstation.

Heat-Conducting PCB Substrate

Thermally-managed substrate spreads heat from compute and imaging silicon away from the patient-contact surfaces.

Temperature Safety Circuit

Independent supervisory circuit gates capture if any contact surface approaches the regulatory thermal limit. Patient-safety boundary, not a software check.

Clinical · Workflow Alignment

Built for the cases where full-arch scanning is hardest.

Full-arch restorative. Implant-supported prosthetics. Clear aligner enrollment at scale. These are the cases where today’s wand scanners slow down, where operator skill dominates outcomes, and where retakes are most expensive. EIKONIS™ is designed specifically for that workload.

§ 01 · In the operatory

What changes in the chair.

CLINICAL WORKFLOW · FOUR-STEP SEQUENCE PATIENT-SEATED · NO OPERATOR SWEEP
01
INSERT

The mouthpiece is positioned in the open mouth.

The intraoral mouthpiece is seated by the patient or operator with the anterior module facing the lips. No sweeping motion. No multi-frame stitching path. Setup is binary — in, or not in.

02
BITE

The patient bites into the bite platform.

Closing onto the device fixes the geometry between maxilla and mandible at the natural bite. The optical heads sit in known positions relative to both arches. Operator-induced motion error is removed by design.

03
CAPTURE

Both arches capture in parallel.

Acquisition runs across all three optical channels simultaneously. Bite is registered natively, in the same pass. Target acquisition window is under twenty seconds for a full-arch dataset.

04
DATASET

A calibrated mesh streams to lab or CAD/CAM.

The output is a single calibrated dataset of both arches plus their bite relationship — exported in STL, PLY, OBJ, or DICOM. Open formats. No vendor lock-in. Ready for restorative, orthodontic, or implant planning workflows.

01 · Registration

One acquisition, both arches.

The patient bites into the device. Both arches are captured together, which removes the maxilla-to-mandible registration step and the stitching artifacts that come with wand-based systems.

02 · Consistency

Less operator variability.

Because the sensor geometry is fixed, scan quality depends less on operator hand-skill and experience. Especially useful in multi-chair practices, DSOs, and training environments.

03 · Throughput

Faster full-arch cases.

Target acquisition times measured in seconds per patient on full-arch cases, versus minutes for current wand systems. Meaningful chair-time implications for high-volume practices.

04 · Downstream

Cleaner data for labs & planning.

A known, calibrated geometry produces datasets that are easier for CAD/CAM and treatment-planning workflows to consume. Fewer iteration cycles between operatory and lab.

§ 02 · Indications

Indications we are designing for.

I / 01

Full-arch implant restorations

All-on-X and related full-arch implant-supported prosthetics, where stitching error compounds across the arch.

I / 02

Fixed & removable full-arch prosthetics

Complete dentures, overdentures, and full-arch fixed prostheses requiring precise occlusal registration.

I / 03

Clear aligner enrollment

High-volume enrollment and monitoring workflows where acquisition consistency is the operational bottleneck.

I / 04

Full-mouth rehabilitation records

Complete-mouth reconstruction cases where records precision drives treatment planning quality.

I / 05

Patient-tolerance-limited cases

Gag reflex, limited opening, pediatric, or special-needs patients where a shortened acquisition window matters clinically.

I / 06

Orthodontic records at volume

Consistent baseline and progression records across multi-doctor orthodontic practices.

§ 03 · Clinical Evidence Plan

How we are building the evidence base.

Clearance of an intraoral scanner does not require a randomized clinical trial — the predicate-based 510(k) pathway accepts bench testing, software validation, biocompatibility, and clinical-performance support against an established device. The evidence strategy below is built to satisfy that pathway and to anchor downstream commercial credibility with KOLs and DSO partners.

3.1 · Predicate analysis

Established intraoral scanner predicates.

Predicate-device analysis is complete. The reference predicates are commercially-cleared optical intraoral scanners with the same intended use — capturing 3D digital impressions of dental anatomy for restorative, orthodontic, and implant workflows. Substantial-equivalence argumentation is structured around shared intended use, comparable technological characteristics, and bench-equivalent performance, with EIKONIS™’s dual-arch architecture documented as a feature variation rather than a new device class.

3.2 · Bench & performance testing

Trueness, precision, and reproducibility.

Performance evidence is generated against ISO 12836 methodology for intraoral scanner accuracy. Trueness is measured against a traceable reference model spanning the indicated arch range; precision is measured across repeat acquisitions per device and across devices. Reproducibility is evaluated across the operator population the device is intended for — clinicians, assistants, and hygienists across single-chair, multi-chair, and DSO settings.

3.3 · Clinical performance support

In-clinic evaluation against intended use.

The clinical-performance protocol is designed to demonstrate that EIKONIS™ produces datasets fit for the indicated downstream workflows — full-arch restorative impressions, orthodontic records, and implant planning — across the arch-size and edentulism range relevant to the intended population. The protocol is being developed with the KOL panel to ensure clinical realism, and is scoped to deliver evidence sufficient for substantial-equivalence rather than the larger sample sizes required for novel-device PMA submissions.

3.4 · KOL & partner program structure

Engaging clinicians upstream of clearance.

The KOL program is structured in three phases: design input (current), pre-clinical evaluation against engineering prototypes, and post-clearance commercial validation. Initial KOLs are recruited across full-arch restorative, implant prosthetics, and aligner orthodontics — the case categories where EIKONIS™’s architecture has the clearest expected advantage. Engagement is documented under formal consulting agreements with disclosure aligned to AdvaMed and Sunshine Act expectations.

3.5 · Real-world data & post-market

The evidence base extends past clearance.

Post-clearance, the platform is positioned to generate longitudinal real-world performance data through normal commercial use — capture-time distributions, retake rates, full-arch case throughput, and lab-side dataset acceptance. This data set anchors continued commercial differentiation against wand-based systems, supports expansion of indication claims in subsequent submissions, and provides the empirical base for international submissions where local clinical data may be required.

§ 04 · KOL Program

Clinical partners we are engaging now.

Odonteikon is engaging a small number of clinical partners for design-input work on full-arch restorative, implant, and high-volume orthodontic workflows. Partners contribute workflow insight and, in later stages, early evaluation access.

If your practice does high volumes of full-arch restorative or implant work, or operates as a multi-location platform where acquisition variability is a known operational issue, we’d welcome a conversation.

Contact Clinical Engagement
Regulatory Status

Investigational device.

EIKONIS™ is not currently cleared or approved for sale in any jurisdiction. FDA 510(k) and CE/MDR pathways are in active preparation. This website describes design intent and targeted performance, not cleared indications.

§ 05 · Questions

What clinicians ask first.

Does the patient actually bite directly on the optics?
+

No. Occlusal loads pass through the bite platform structure — the sensor windows sit behind a protective optical interface calibrated for capture through a thin transparent barrier. The autoclavable tip plus single-use barrier sleeve is the same reprocessing model clinicians already follow for wand-based intraoral scanners, and the patient's teeth never contact the sensors directly.

How does a fixed geometry handle variation in arch shape and size?
+

The mouthpiece housing accommodates the anatomical range of adult arches through its horseshoe geometry and clearance envelopes, and the capture algorithm is designed to produce a calibrated dataset independent of how the patient’s arches sit within those envelopes. Clinical evaluation will include the full range of arch sizes relevant to the intended indications; edge-case protocols for restricted opening and pediatric populations are a specific focus of the KOL program.

Will EIKONIS™ produce data compatible with the labs and planning software we already use?
+

Yes. Export formats are standard: STL, PLY, OBJ, and DICOM mesh. The workflow integration layer is designed so that a clinician does not change their lab, their CAD/CAM system, or their treatment-planning software to adopt EIKONIS™. Our workflow thesis is that a cleaner calibrated dataset should make every downstream tool work better, not require replacing them.

What is the learning curve for a new operator?
+

The design goal is that there isn’t one. A wand-based scanner rewards hours of motion practice; a mouthpiece architecture shifts that burden onto the device itself. Once the patient is seated and positioned, the acquisition step is essentially binary: bite, trigger, capture. Training focus is therefore on patient prep, tip handling, and case selection — not on operator hand-skill.

Is EIKONIS™ intended to replace our existing scanner or supplement it?
+

Both answers are valid depending on the practice. For single-chair restorative practices, EIKONIS™ is positioned as a primary scanner for full-arch and complex cases. For multi-chair practices and DSOs, it may initially sit alongside existing wand systems and become the default for the case types — full-arch, implant, high-volume aligner enrollment — where its architecture offers the clearest advantage.

How does reimbursement work for EIKONIS™ scans?
+

Intraoral scanning is currently reimbursed under the same CDT coding framework across existing scanner platforms. EIKONIS™ is designed to produce records that satisfy the same documentation and clinical requirements. We are not expecting a new reimbursement category to be required; we are expecting existing full-arch records workflows to become faster and more repeatable.

When will EIKONIS™ be available, and how do I get involved earlier?
+

Commercial availability is sequenced behind FDA 510(k) clearance — see the roadmap on the Platform page for the current planned cadence. Before then, high-volume full-arch practices and DSO clinical leadership can engage through the KOL program. Write to clinical@odonteikon.com with a brief description of case mix and volume, and we will be in touch.

Investors · Diligence Overview

A hardware thesis with an architectural moat.

Odonteikon is a pre-commercial medical-device company advancing a dual-arch intraoral capture platform designed to replace the sequential wand scan with a calibrated, bite-stabilized acquisition geometry. The investment thesis is not a better wand — it is a different category.

§ 01 · The thesis

Three reasons the category is open.

The intraoral scanner category has consolidated around four wand-based platforms and twelve years of iterative optimization on the same motion model. Every major improvement — faster frame rates, better stitching, AI artifact removal — has worked around the operator, not replaced them. That optimization curve is flattening at the exact moment full-arch and implant case volume is growing fastest.

EIKONIS™ is architecturally upstream of that curve. By fixing the sensor geometry and acquiring both arches in parallel, the platform eliminates several classes of error — stitching, inter-arch registration, operator-dependent pacing — that wand systems can only mitigate. The result is a defensible imaging modality, not a better feature on an existing one.

§ 02 · Why now

Three forces converging on the category.

F · 01

Full-arch case mix is rising.

Implant-supported full-arch restorations and clear aligner therapy — the two case types where wand scanning is weakest — are growing fastest in clinical case mix. The cases where the existing technology struggles are the cases driving practice revenue.

F · 02

The DSO operating model demands repeatability.

Dental Service Organizations now consolidate a meaningful share of US clinical activity. DSO economics depend on cross-operator consistency that wand-based capture, by design, cannot deliver. EIKONIS™’s fixed-geometry architecture is the answer to a problem the market is now structurally optimized to pay for.

F · 03

The optimization curve has flattened.

Twelve years of wand-based iteration have moved acquisition speed from minutes to seconds, but the underlying error sources — stitching, registration, operator pacing — persist. The category is open not because it is unworked, but because the existing architecture has reached its asymptote.

§ 03 · The moat

Four layers of defensibility.

M · 01

Architecture IP.

The patent family covers not a feature but a category: dual-arch simultaneous capture inside a calibrated bite-stabilized geometry. Competitors building on the same thesis would operate inside the claim perimeter.

M · 02

Workflow integration.

Outputs are STL, PLY, OBJ, and DICOM mesh — the formats every lab, CAD/CAM system, and planning software already consumes. Adoption does not require ecosystem change.

M · 03

Regulatory entrenchment.

510(k) clearance, QMS, and clinical evidence accumulated for Generation 1 compound into Generations 2 and 3. The platform roadmap is sequenced to preserve that regulatory history across form-factor evolutions.

M · 04

Data surface.

Calibrated, repeatable datasets across operators and practices create a longitudinal data asset that wand-based systems cannot match. That data surface becomes the foundation for AI-assisted capture validation and treatment planning downstream.

§ 04 · Stage & round

Where the round stands.

Stage. Pre-commercial. The company is currently in engineering validation with active patent prosecution, predicate-device analysis complete, and the KOL program engaging clinical partners for design input and evaluation pathways.

Round. Odonteikon is preparing a priced round to fund the clinical prototype, 510(k) preparation, and initial commercial engineering. The diligence package covering IP, regulatory strategy, financial model, and use-of-funds detail is available to qualified parties under NDA.

40%
Category 01
Engineering & prototype
Clinical-grade prototype build-out, optical validation, thermal characterization, firmware maturity.
25%
Category 02
Regulatory & QMS
510(k) preparation, QMS implementation, clinical evaluation support, pre-submission activity.
20%
Category 03
IP & partnerships
Patent prosecution, PCT national phases, OEM partnership development, clinical advisory formation.
15%
Category 04
Operations & runway
Core team operations, strategic hiring, administrative scaffolding through milestone completion.

Allocation targets are indicative. Final allocation is subject to round size and closing terms.

§ 05 · Traction & validation

Where credibility is accumulating.

Pre-clinical, pre-revenue companies build credibility through accumulating signals — technical, regulatory, and commercial. Below is the current state of those signals, framed honestly. We update this list when a milestone moves rather than when a news cycle is convenient.

T · 01
Technical

Engineering validation in progress.

Optical-channel architecture, bite-stabilization geometry, and thermal substrate design are in active engineering validation. Bench-level acquisition results, thermal modeling, and optical characterization are documented in the technical data packet of the diligence package.

T · 02
IP

Patent family active in prosecution.

The foundational patent family covering dual-arch simultaneous acquisition geometry, bite-stabilization mechanics, thermal substrate design, and the workflow integration layer is filed and active. Continuations are sequenced against commercial-generation milestones; international phases are scoped against priority dates.

T · 03
Regulatory

Pathway analysis complete.

Predicate-device analysis, 510(k) submission strategy, and pre-submission (Q-Sub) preparation are complete. The path to FDA clearance is documented at the level of testing scope, evidence acquisition, and submission-section assignment.

T · 04
Clinical

KOL program engaging design partners.

Clinical partners are being engaged across full-arch restorative, implant prosthetics, and high-volume orthodontics for design input and pre-clearance evaluation. Formal advisory engagements are documented under consulting agreements aligned with AdvaMed and Sunshine Act expectations.

T · 05
Commercial

DSO and lab interest mapped.

The commercial interest map covers DSO clinical-leadership conversations, lab-partner technology assessments, and OEM partnership exploration. Specific names and engagement depth are documented in the diligence package.

T · 06
Operational

Engineering team build-out underway.

Senior hardware, optics, embedded systems, and regulatory affairs hiring is sequenced against the 510(k) preparation timeline. The team is being built for the durability of a multi-generation platform company, not the convenience of a single launch.

§ 06 · Commercial roadmap

Phases to commercial scale.

The path from current stage to commercial scale runs through four phases, each gated by a specific milestone. Phase boundaries are realistic rather than aspirational; we publish the framework here without committing to specific calendar dates because regulatory and clinical timelines are inherently variable.

P · 01
Engineering validation
Current

Optical, mechanical, thermal, and software validation against design targets. Production-equivalent unit build-out is the gating event for Phase 02.

P · 02
Regulatory preparation
Adjacent

Pre-submission (Q-Sub) interaction with FDA. Bench testing campaign on production-equivalent units (biocompatibility, electrical safety, EMC, performance, reprocessing). Submission package compilation.

P · 03
510(k) review & clearance
Forecast

FDA review, additional information cycles, clearance. ISO 13485 QMS completion and FDA inspection readiness in parallel. Initial commercial manufacturing partnership confirmed.

P · 04
Commercial launch
Horizon

Initial commercial deployment in target accounts (full-arch restorative practices, DSO pilot programs, lab-partner workflows). CE/MDR conformity assessment in parallel for European market entry.

Phase boundaries are realistic, not committed dates. Specific calendar timelines are documented in the diligence package and updated against actual milestone progress.

§ 07 · Investor questions

What investors ask first.

How is this different from a better wand scanner?

It is not a better wand. The wand scanner relies on operator motion and software stitching as the core mechanism of capture; EIKONIS™ replaces both with fixed-geometry simultaneous acquisition. Architecturally upstream of incremental wand improvement, not on the same axis.

What is the regulatory pathway and risk?

Traditional 510(k) under product code NOF (21 CFR 872.3661), citing substantial equivalence to legally-marketed intraoral scanners with same intended use. The architectural differences are positioned as feature variations rather than novel device class. The Q-Sub interaction with FDA is structured to confirm this pathway in writing before significant testing budget is committed.

How do you make money?

Hardware unit sales to clinical practices and DSOs, with consumable revenue from single-use barrier sleeves on a per-patient basis. Recurring software and data services emerge in Generation 2 alongside the wireless platform. Detailed unit economics, ASP assumptions, and recurring-revenue framework are in the diligence package.

Who are the realistic acquirers?

The strategic-acquirer landscape includes incumbent intraoral scanner OEMs (3Shape, Align Technology, Dentsply Sirona, Carestream), dental-equipment platforms (Patterson, Henry Schein, Benco), and digital-dentistry software platforms with hardware integration ambitions. The platform’s open output-format strategy preserves OEM partnership optionality alongside standalone commercial pathways.

What stops an incumbent from copying this?

The patent family is the structural answer. The architectural decisions — dual-arch simultaneous capture inside a calibrated bite-stabilized geometry — are claimed at the architecture level rather than at the feature level. Competitors building on the same thesis would operate inside the claim perimeter. Detail in the IP section of the diligence package.

Why hasn’t this been done before?

Three reasons. First, the wand model became the industry standard early enough that subsequent investment compounded around it. Second, simultaneous dual-arch capture requires several engineering disciplines (optics, mechanics, thermal, embedded) to converge on a single product — difficult inside a wand-optimized organization. Third, the case-mix economics that make the dual-arch advantage commercially material (full-arch implant, complex restorative, aligner case volume) are recent.

What are the biggest risks?

Three categories. (1) Regulatory: FDA could request in-human clinical performance support beyond bench testing; mitigated through Q-Sub feedback before testing campaign commitment. (2) Clinical: patient tolerance of the bite-stabilized form factor must be validated through human factors studies; mitigated through KOL-engaged formative evaluations. (3) Commercial: incumbent scanner platforms have entrenched DSO and lab relationships; mitigated through open-format output strategy that does not require ecosystem replacement.

§ 08 · Diligence

What the diligence package contains.

  • DP · 01 Patent family summary — core filings, claim architecture, jurisdictional strategy, continuation roadmap.
  • DP · 02 Technical data packet — measured values against design targets, thermal modeling, optical characterization, bench-level acquisition results.
  • DP · 03 Regulatory strategy — predicate-device analysis, 510(k) submission plan, QMS status, CE/MDR pathway.
  • DP · 04 Financial model — 48-month operating plan, runway scenarios, post-clearance revenue assumptions, unit economics.
  • DP · 05 Market analysis — TAM/SAM/SOM segmentation, competitive landscape, KOL engagement register, DSO interest map.
  • DP · 06 Corporate & governance — cap table, entity structure, IP ownership chain, operating agreements.
§ 09 · Request access

Qualified investors, please reach out directly.

Access to the diligence package is granted under NDA to qualified investors with sector alignment and appropriate cycle length. Introductions from existing dental-medtech operators, strategic acquirers, and regulatory-experienced funds are welcomed.

Request Diligence Package Introduce Yourself
Dispatches · Company Updates

Notes from the workshop.

Odonteikon publishes selectively. Dispatches appear here when a milestone, filing, or engagement crosses a bar worth stating publicly — not when a news cycle is convenient. This page is the authoritative record.

§ 01 · Recent

Selected dispatches.

2026 · Q2 Company

Odonteikon reissues corporate website and platform narrative.

Revised public positioning published, establishing the dual-arch intraoral capture thesis, the four-subsystem platform architecture, and the three-generation commercial roadmap under a unified brand system.

Published
2026 · Q2 IP

Core patent family filings advanced.

The foundational patent family covering dual-arch simultaneous acquisition geometry, bite-stabilization mechanics, thermal substrate design, and the workflow integration layer is active in prosecution across US and PCT jurisdictions. Continuations are staged against commercial-generation milestones.

Filed
2026 · Q2 Clinical

KOL engagement program opens for high-volume full-arch practices.

Odonteikon is engaging a small number of clinical partners for design input on full-arch restorative, implant-supported prosthetics, and high-volume orthodontic workflows. Practices with relevant case mix and volume are invited to contact the clinical desk.

Open
2026 · forthcoming Regulatory

Pre-submission FDA meeting in preparation.

Predicate-device analysis is complete. A pre-submission (Q-Sub) meeting with FDA CDRH is being prepared to align on the submission strategy, clinical data expectations, and review pathway for the Generation 1 tethered device.

Planned
2026 · forthcoming Round

Priced round preparation underway.

Odonteikon is preparing a priced round to fund clinical prototype, 510(k) preparation, and initial commercial engineering. Qualified investors may request access to the diligence package via the Investors page.

In prep

Press and analyst inquiries: engagement@odonteikon.com

§ 02 · Engineering notes

Selected technical writing.

Short, substantive notes from inside the engineering work. Written in the company voice rather than bylined; published when the technical decision is settled enough to explain publicly without compromising IP or competitive position.

2026 · Q2 Geometry ~4 min read

Why three optical channels, not four or five.

The most common question we get from optics engineers reviewing the architecture is why we settled on three channels for full-arch dual-arch coverage rather than four, five, or more. The answer is a constraint cascade, not a free choice.

Each additional optical channel introduces a calibration interdependency that compounds across the manufacturing process. Two channels need a single relative-pose calibration. Three need three pairwise calibrations and a global consistency check. Four need six pairwise calibrations. Five need ten. The metrology cost grows quadratically while the field-of-view coverage gain grows sub-linearly.

The horseshoe geometry of a typical adult dental arch can be covered, with overlap margin, by three channels positioned at the anterior labial midline and the two posterior buccal regions. The anterior channel sees both lower incisors and upper incisors simultaneously. The posterior channels see the molar and premolar regions on each side. Coverage at the canine-premolar transition is provided by overlap from the anterior channel on the lingual side and the buccal channels on the buccal side.

Adding a fourth channel — for example, a dedicated lingual channel for the molar regions — gains marginal coverage at the cost of doubling the calibration matrix. The marginal coverage gain is in surface regions that are already imaged at acceptable density; the calibration cost is borne on every unit shipped.

The three-channel architecture is not the maximum possible coverage architecture. It is the maximum-coverage architecture that does not pay a manufacturing-cost penalty disproportionate to the imaging-quality gain. The decision was driven by metrology economics, not by the optical limit.

2026 · Q2 Calibration ~5 min read

Factory calibration vs. in-field calibration: the architectural choice.

A dual-arch capture architecture has two reasonable approaches to maintaining inter-channel pose accuracy: factory-set with mechanical retention, or in-field re-calibration with a reference target. We chose the first. Here is the reasoning.

In-field calibration would let the system tolerate gradual mechanical drift over the device lifetime — a real concern for any structural component subjected to thousands of autoclave cycles, occlusal bite loads, and routine handling. The trade-off is that the clinician (or DSO clinical staff member) becomes responsible for periodic calibration runs, which introduces operator burden and creates a state-dependency in capture quality that we explicitly designed out of the architecture.

Factory calibration with mechanical retention pushes the engineering burden upstream. The shell material, internal mounting structure, and thermal-spreader layer are all selected and arranged to maintain optical-channel relative pose across the full expected service envelope: occlusal bite cycles, autoclave thermal cycles, drop-event mechanical shocks, and ambient temperature variation in operatory environments. The calibration retention claim is then validated as a bench test (Test 4.5 in the testing matrix) at 0, 25, 50, and 100+ autoclave cycles — a single validated claim made once at design release rather than a recurring per-unit operational requirement.

The architectural consequence is that material selection (shell polymer grade, mounting structure rigidity) and assembly tolerances (channel-to-substrate bond integrity) become part of the regulatory submission. Calibration is a documented design output, not a use-time procedure. This is the pattern most cleared intraoral scanners follow at the channel level; we extend it to the inter-channel level.

The decision is not absolute. A future generation of the platform could move to in-field calibration if the use-case calls for it — for example, a portable variant where the cost-benefit calculus changes. The Generation 1 architecture, however, treats calibration as a manufactured-in property of the device, not a runtime concern.

2026 · Q2 Materials ~4 min read

Polycarbonate, PEI, and the autoclave-cycle question.

The shell material decision sits at the intersection of biocompatibility, optical translucency, mechanical rigidity, and autoclave thermal cycling. Two material classes meet all four constraints — medical-grade polycarbonate and polyetherimide (PEI). The choice between them is more nuanced than a spec table suggests.

Polycarbonate is the lower-cost choice with established medical-device pedigree, broad supplier base, good optical clarity, and adequate autoclave tolerance for the service life we target. Its weak point is repeated steam exposure: hydrolysis of the carbonate linkage at elevated temperature progressively reduces mechanical properties over many cycles. For a device claiming ≥100 autoclave cycles, polycarbonate is on the edge of its envelope — tractable, but requires careful grade selection and stabilizer chemistry, and the cycle-life claim has to be validated rather than assumed.

PEI is the more expensive choice with a smaller medical-device supplier base but a substantially better autoclave envelope. Its glass transition temperature is well above the autoclave cycle peak, hydrolysis resistance is markedly better than polycarbonate, and dimensional stability across thermal cycles supports the calibration retention claim discussed above. The trade-offs are unit cost (notable on a high-volume disposable-adjacent device), optical clarity (slightly inferior to optical-grade polycarbonate but acceptable for our internal-channel application), and supplier diversity in medical grades.

The current design holds the choice open between the two grades pending the cycle-life validation results. The bench testing protocol exposes representative shell samples to the full claimed cycle count under realistic loading and humidity profiles, with mechanical and optical property measurements at intervals. The grade that passes with the most retained margin wins.

What the public site cannot show is that this decision is being made on data, not on materials science folklore. The diligence package documents the test protocol, sample plan, and decision criteria. What the site can show is that the decision is real and the criteria are written down.

Engineering notes are published when a technical decision is settled enough to explain without compromising IP or competitive position. Detailed validation data and decision criteria are documented in the diligence package available under NDA.

Partners · Engagement Models

The platform is open. The partnerships are deliberate.

EIKONIS™ outputs to STL, PLY, OBJ, and DICOM — the formats every dental lab, CAD/CAM platform, treatment-planning system, and orthodontic workflow already accepts. The platform is open by design. The commercial relationships around it are deliberate: structured to align incentives across the partner’s commercial model and the platform’s clinical and regulatory posture.

§ 01 · How we partner

Four engagement domains.

Odonteikon engages partners across four domains, each with its own commercial logic and engagement model. Below is the framework for each. Specific terms, exclusivity considerations, and timing are discussed under NDA with qualified counterparties.

P · 01
Lab partners

Dental laboratories consuming scan output.

Independent labs and lab groups receiving STL/PLY/OBJ datasets for restorative, prosthetic, and orthodontic case fabrication. Partnership focuses on workflow validation, output-format compatibility, and case-throughput optimization — not on scanner ownership.

P · 02
DSO partners

Dental Service Organizations adopting at scale.

Multi-location DSOs deploying EIKONIS™ across clinical sites. Partnership focuses on cross-operator repeatability, central data management, training and onboarding programs, and operational integration with existing chairside workflows.

P · 03
OEM & strategic partners

Technology integration and distribution.

Established intraoral imaging OEMs, dental-equipment distributors, and treatment-planning platforms exploring technology integration, distribution agreements, or strategic partnership. Partnership scope ranges from co-marketing through full OEM integration of the EIKONIS™ capture core.

P · 04
Clinical research partners

Academic and KOL clinical sites.

Dental schools, academic medical centers, and high-volume clinical practices participating in pre-clearance evaluation, post-clearance clinical performance studies, and longitudinal data collection. Engagement is governed by formal research agreements aligned with institutional IRB processes.

§ 02 · Lab partners

Workflow integration without ecosystem change.

Lab partners are the most direct downstream consumers of EIKONIS™ output. The platform’s open output-format strategy is designed specifically to remove ecosystem-change risk for lab partners: the datasets EIKONIS™ produces are the same dataset formats labs already process from existing intraoral scanners, in the same case-routing workflow.

Lab-partner engagements focus on three areas: case-quality validation against the lab’s existing scanner-in-input baseline; throughput optimization where dual-arch capture removes upstream bottlenecks; and pre-clearance evaluation programs where labs receive scan datasets from KOL practices for fabrication validation.

§ 03 · DSO partners

Repeatability built for multi-location operating models.

The DSO operating model concentrates clinical operations across many sites and many operator roles. The technologies that work at single-doctor solo practices are routinely the wrong technologies for that operating context, because the variability they tolerate at one chair compounds across hundreds of chairs.

EIKONIS™’s fixed-geometry architecture is the structural answer to that compounding-variability problem. Scan quality does not depend on which clinician, hygienist, or assistant operates the device; the bite-stabilized acquisition and factory-calibrated optical channels produce calibrated output independent of operator technique.

§ 04 · OEM & strategic

Technology integration and category positioning.

EIKONIS™ is a category-defining capture architecture rather than a feature on an existing scanner platform. That positioning creates several shapes of strategic engagement: technology integration where the EIKONIS™ capture core is incorporated into a partner’s broader product line; distribution agreements through dental-equipment channels with established sales-and-service infrastructure; and strategic partnership where category positioning, IP cross-licensing, or commercial co-development is appropriate.

The patent family is the strategic anchor. Architectural-level claims around dual-arch simultaneous capture and bite-stabilized geometry mean that partnership conversations begin with a clear IP boundary: what is owned by Odonteikon, what is partner-owned, and how the two relate. Strategic-partnership conversations are conducted under bilateral NDA after preliminary fit assessment.

§ 05 · Clinical research

Academic and KOL engagement.

Clinical research partners are the engine of the evidence base. Pre-clearance, KOL practices and academic sites participate in formative evaluation, design feedback, and human-factors validation. Post-clearance, the same sites become the foundation for clinical performance studies, longitudinal outcomes data, and the publication record that drives broader adoption.

Clinical research engagements are governed by formal research agreements, including IRB approval where required, informed consent protocols, and data-use agreements. Sunshine Act and AdvaMed compliance are baseline requirements; financial relationships are documented and disclosed per applicable regulatory and institutional standards.

§ 06 · Begin a conversation

The right desk for the right conversation.

We believe in talking before papering. Initial conversations are best had directly — the right partnership shape often emerges through dialogue rather than from a fixed proposal. Reach the appropriate desk below; the team responds within five business days.

Lab · DSO · OEM · Strategic
Clinical Research · KOL · Academic
Company · Operating Philosophy

A platform company for full-arch digital dentistry.

Odonteikon exists to do one thing well: make full-arch intraoral capture faster, more repeatable, and more useful to the downstream digital workflow than today’s wand-based systems allow.

§ 01 · Origin

Why Odonteikon exists.

The intraoral scanner category has been refined for two decades around a single architectural choice: a hand-held wand swept across each arch by a clinician. Every meaningful improvement in the years since — faster frame rates, better stitching, AI-assisted artifact removal — has worked around that choice rather than questioned it.

Odonteikon was founded on the observation that the choice itself is the bottleneck. Wand scanners produce excellent data for single-quadrant, single-arch cases. They produce noticeably worse data for the cases that increasingly drive clinical revenue: full-arch implant restorations, complex prosthetics, high-volume aligner workflows. The technology is not failing on the easy cases — it is straining on the cases that matter most.

The architectural answer is to remove the operator-driven motion model entirely. EIKONIS™ captures both arches simultaneously through a fixed-geometry mouthpiece — not because dual-arch capture is novel, but because it is the architecture the cases the market is moving toward actually need. The company exists to bring that architecture to clinical reality, and to build the platform durably enough to carry through three generations of commercial evolution.

§ 02 · Mission

Precision imaging, infrastructure-grade.

M · 01

Build for the cases that matter most.

Full-arch restorative, implant-supported prosthetics, and high-volume orthodontic workflows are the case types where the existing technology underdelivers and the patient and clinical stakes are highest. EIKONIS™ is engineered for those cases first, and for everything else as a downstream benefit.

M · 02

Engineer for repeatability across operators.

The dental workforce has expanded to include hygienists, dental assistants, and DSO clinical staff capturing impressions that previously required dentist time. Repeatability across this operator population is no longer a feature; it is a precondition for adoption. Our architecture starts from that constraint.

M · 03

Output to the workflow that already exists.

Every lab, CAD/CAM platform, and treatment-planning system already accepts STL, PLY, OBJ, and DICOM. Adoption of EIKONIS™ should require no ecosystem change. The platform’s data thesis is that better upstream capture should make every downstream tool work better, not require replacing them.

M · 04

Sequence the platform for durability.

Generation 1 ships tethered. Generations 2 and 3 carry the same imaging core into wireless and dock-charged form factors. The 510(k), QMS, and clinical evidence accumulated for Generation 1 compound forward. The roadmap is sequenced for durability across regulatory, manufacturing, and commercial cycles — not the convenience of a single launch.

§ 03 · How we work

Three operating principles.

P · 01

Engineering-led.

The product is designed around mechanical and optical constraints first, marketing second. Claims on this site reflect design targets and filed IP, not finished specifications.

P · 02

Patient.

Dental imaging is a regulated, clinically rigorous field with long adoption cycles. We are building the company to be durable across those cycles rather than optimized for a single launch.

P · 03

Candid.

Where a capability is shipping, we say so. Where it is a design goal or a roadmap item, we label it that way. No platform-speak, no conditional hedges used as disguise.

§ 04 · Footprint

Where we operate.

Primary

Grand Rapids, Michigan

Operational Headquarters
100 Monroe Center NW
Suite 820
Grand Rapids, MI 49503
United States

Engineering, product, clinical engagement, and US commercial operations. All operating activity of Odonteikon Corporation is based here.

IP Entity

George Town, Grand Cayman

Intellectual Property Holding Entity
Harbour Place
103 South Church Street, 4th Floor
George Town, Grand Cayman KY1-1002
Cayman Islands

International corporate structure and IP governance. Non-operating entity.

§ 05 · Leadership

The people behind the platform.

Odonteikon is structured for the durability of a multi-generation platform company rather than the speed of a single-product launch. Senior team build-out is sequenced against the 510(k) preparation timeline, with formal announcements made as engagements are executed.

Clinical Advisory Board

In formation

Odonteikon is assembling a clinical advisory board drawn from prosthodontics, oral & maxillofacial surgery, orthodontics, and DSO clinical leadership. Initial advisor engagements are documented under formal consulting agreements; named announcements follow as engagements are executed.

Disciplines Prosthodontics · OMS · orthodontics · DSO clinical leadership
Engineering · Hardware

In build-out

Senior hardware, optics, and embedded-systems hires sequenced against engineering validation milestones. Specific functional leadership hires (Mechanical Engineering, Optical Engineering, Embedded Systems, Manufacturing Engineering) named prior to commercial release.

Functions Mechanical · optics · embedded · firmware · manufacturing
Regulatory & Quality

In build-out

RA and QA leadership engaged before 510(k) submission and ISO 13485 QMS implementation. Initial work is being structured with experienced fractional consultants; full-time leadership named alongside QMS implementation milestones.

Functions RA · QMS · clinical evaluation · post-market surveillance
Commercial & Partnerships

Forthcoming

Commercial leadership engaged ahead of clearance to develop DSO and lab-partner relationships, OEM partnership exploration, and the pre-launch commercial readiness program. Announcement aligned to clearance timeline.

Channels DSO · lab-partner · OEM · international distributor
Board of Directors

Constituting

Board structure follows the priced round closing. Investor representatives, an independent director with medical-device commercial experience, and the founder constitute the initial board. Board observer rights extended to material round participants.

Composition Founder · investor representatives · independent director
§ 06 · Advisors

Outside expertise around the platform.

Odonteikon engages outside expertise across four domains where the company benefits from deep, specialized perspective: clinical specialty, regulatory, commercial, and technical. Engagements are formal consulting relationships documented under written agreements aligned with AdvaMed and Sunshine Act expectations.

A · 01

Clinical specialty advisors.

Practicing clinicians providing design input, indication-scope feedback, and pre-clinical evaluation across full-arch restorative, implant prosthetics, oral & maxillofacial surgery, and orthodontics. Engagement structure: formative input during engineering validation; pre-clearance evaluation on engineering-validation units; post-clearance commercial validation.

A · 02

Regulatory & quality advisors.

Senior RA and QMS practitioners with NOF / dental-device 510(k) experience and ISO 13485 implementation history. Engagement structure: predicate analysis review; Q-Sub package preparation; testing campaign protocol review; submission package compilation.

A · 03

Commercial & channel advisors.

Senior operators with relevant commercial experience: DSO clinical-leadership perspective, dental-equipment distribution channel knowledge, lab-partner commercial development, and OEM partnership precedent. Engagement structure: ongoing strategy and pre-launch commercial readiness.

A · 04

Technical & manufacturing advisors.

Specialists in optical metrology, structured-light system design, medical-device contract manufacturing, and biocompatible polymer engineering. Engagement structure: focused technical reviews at design-control gates and manufacturing readiness milestones.

Specific advisor names and engagement details are documented in the diligence package available under NDA.

§ 07 · Engage

Reach the right desk.

Partnerships · OEM
Clinical · KOL Program